1. Field of the Invention
The present invention relates to a multi-lumen intravenous extension for transmitting liquids to a position adjacent a body and for mixing the fluids as close as possible to the point where they are injected into the blood stream of the body. For such a purpose, the multi-lumen intravenous extension of the present invention includes at least two, and possibly up to five, lumens, namely a main lumen for a carrier fluid, such as a saline solution, and at least one, and up to four, satellite lumens for carrying medication(s) to the body and mixing the medication(s) as close as possible to the point of input into the blood stream of the body at a proximal end of an intravenous catheter.
2. Description of the Prior Art
Heretofore catheters have been proposed for mixing components in the catheter prior to delivery of the mixture to a human body. Examples of analogous and non-analogous catheters are disclosed in the following analogous and non-analogous U.S. patents:
Thomsen and the Oswald et al. both disclose manifolds for injecting drugs, medications or liquids into an intravenous catheter or conduit.
Dake et al. disclose a catheter having a central lumen for receiving a guide wire and four satellite lumens that extend coaxially with the central lumen. The outer periphery of the catheter has openings that communicate, respectively, with the four different satellite lumens for enabling four different fluids to be introduced into the vessel in which the catheter is inserted.
Pressman et al. disclose a component mixing catheter including an inner tubular body having a central lumen for a main fluid and an outer tubular body with an annular space between the inner tubular body and the outer tubular body for receiving a second liquid and the wall of the inner tubular body having holes therethrough for introducing the second liquid from the annular space into the main lumen where the second liquid is combined with the main fluid.
Vaillancourt shows, in FIG. 8, a septated or partitioned internal lumen where a micro-bore lumen and septal wall 51 are co-extruded within the internal diameter or circumference of the outer tube 52 such that both the diameter of the micro-bore lumen and septal wall extend inward and protrude into the circumference defining the lumen of the outer tube 52. In other words, the intraluminal position of the micro-bore lumen and septal wall 51 reduces the cross-sectional area of the fluid conveying lumen of the outer tube 52. This intraluminal configuration is consistent with the other embodiments of the Vaillancourt patent because Vaillancourt describes that the satellite tubes and lumen are contained within the lumen of the outer tube 52. In Vaillancourt, all disclosed embodiments reduce the cross-sectional area of the outer tube 52.
Weenig discloses a self-clearing extension set for delivery of fluid to a patient. FIG. 2 of Weenig discloses a dual lumen extension tube 90 that is virtually identical to FIG. 8 of Vaillancourt. Just like in Vaillancourt, Weenig discloses a small lumen 156 and separating membrane 158 extending inward and protruding into the circumference defining the large lumen 154. In other words, the intraluminal position of the small lumen 156 and wall 158 reduces the cross-sectional area of the fluid conveying large lumen 154.
Flow in a tube is described by the Hagen-Poiseuille Law, which provides that flow is linearly proportional to pressure of the fluid in the tube, viscosity of the fluid, and length of the tube, but is exponentially proportional to the radius of the tube. See Engineering Applications of Fluid Mechanics, J. C. Hunsaker and B. G. Rightmire, McGraw-Hill Book Company, Inc., 1947, indicating the principles of the Hagen-Poiseuille Law. Specifically, the Hagen-Poiseuille Law is described by the formula:   Q  =            π      ⁢              xe2x80x83            ⁢                        r          4                ⁢                  (                                    P              1                        -                          P              2                                )                            8      ⁢              xe2x80x83            ⁢      μ      ⁢              xe2x80x83            ⁢      L      
where:
Q is flow rate through a tube;
r is the radius of the tube;
xcexc is the viscosity of the fluid;
L is the length of the tube; and
P is the pressure of the fluid.
Therefore, for a small decrease in the radius of the tube, a substantial reduction in flow ensues.
For the tubular embodiments described in Vaillancourt, i.e., for an inner tube 51 having an interior diameter of 0.020 inches, the micro-bore tube 51 occupies a significant amount of space and flow rate through Vaillancourt""s outer tube 51 is affected to a substantial degree when viewed in terms of delivering a medication to a patient. Contrast Vaillancourt at col. 6, lines 56 to 60. Specifically, the embodiment shown in FIG. 8 of Vaillancourt, which is partially within the wall of outer tube 52, decreases flow in outer tube 52 by at least 18 percent. If a tube such as inner tube 51 is inserted entirely within outer tube 52 as illustrated in FIGS. 6, 7, 9, and 10 of Vaillancourt, then flow is decreased by at least 28 percent. If the embodiment of Vaillancourt was changed to place two inner tubes 51 within outer tube 52, then flow in outer tube 52 is decreased by at least 54 percent.
Similarly, for the tubular embodiment described in Weenig, small lumen 156 occupies a significant amount of space and flow rate through Weenig""s large lumen 145 and is affected to a substantial degree when viewed in terms of delivering a medication to a patient.
Specifically, the embodiment shown in FIG. 2 of Weenig, having the small lumen 156 partially within the large lumen 154, decreases flow in large lumen 154 by approximately 15 to 20 percent.
Such a decrease in flow within the Vaillancourt outer tube 52 or the Weenig large lumen 154 is entirely undesirable. The purpose of fluid conveyed in the lumen of outer tube 52 is for patient fluid maintenance and volume fluid bolus, both of which may require delivering a large volume of fluid in a short period of time. Compromising the ability to rapidly convey a large volume of fluid could have detrimental effects on the patient.
O""Neil discloses three or four entirely separate lumens that are each glued/fastened into a common connector 42. See O""Neil at FIGS. 6 and 8. In each multi-lumen embodiment, the largest lumen 4 is compressed and, therefore, obstructed.
Tsuchida discloses a multi-lumen catheter. This catheter is shown in FIG. 1b. As set forth therein, each of the lumen are triangular in shape.
Finally, Pursley discloses a system for manufacturing catheters. However, Pursley is expressly distinguished from extrusion processes.
It is accordingly an object of the invention to provide a multi-lumen intravenous extension and method for conveying medicinal fluids that overcome the hereinafore-mentioned disadvantages of the heretofore-known devices and methods of this general type and that are configured to integrate with existing standardized infusion systems. The multi-lumen intravenous extension is positioned between an intra-vascular or intravenous access site and an infusion system typically including a supply of saline and syringes for injecting drugs, medications or other liquids into the multi-lumen intravenous extension. The multi-lumen intravenous extension allows for organized and efficient delivery and administration of a wide variety of medications and pharmaceutical agents, using less priming volume, minimizing effects of carrier fluid rates, and requiring only a minimal amount of medication mixing.
With the foregoing and other objects in view, in a drug delivery system having a medicinal fluid supply system with at least two supplies independently supplying at least two medicinal fluids at a distal connector, there is provided, in accordance with the invention, an extension including a mixing connector defining a mixing chamber to be fluidically connected to a vascular access device for simultaneously supplying the at least two medicinal fluids to a patient, and an intramural extrusion tube for conveying the at least two medicinal fluids independent from one another, the tube having a proximal end capable of being connected to the distal connector, a distal end connected to the mixing connector, a single, substantially ring-shaped tubular wall having a wall inner circumference and a wall outer circumference, the wall defining at least two channels including a substantially circular primary channel for conveying a first of the medicinal fluids, the primary channel having a primary channel outer circumference defined by the wall inner circumference, a proximal opening capable of being fluidically connected to a first of the supplies to supply the first medicinal fluid to the primary channel, and a distal opening fluidically connected to the mixing chamber for substantially preventing over-pressurization of the vascular access device, and a substantially circular secondary channel for conveying a second of the medicinal fluids, the secondary channel entirely disposed between the wall inner circumference and the wall outer circumference and having a proximal opening capable of being fluidically connected to a second of the supplies to supply the second medicinal fluid to the secondary channel and a distal opening fluidically connected to the mixing chamber for substantially preventing over-pressurization of the vascular access device.
With the objects of the invention in view, there is also provided a drug delivery system, including a medicinal fluid supply system having a distal connector and at least two supplies independently supplying at least two medicinal fluids at the distal connector, a mixing connector defining a mixing chamber, an intramural extrusion tube for conveying the at least two medicinal fluids independent from one another, the tube having a proximal end connected to the distal connector, a distal end connected to the mixing connector, a single, substantially ring-shaped tubular wall having a wall inner circumference and a wall outer circumference, the wall defining at least two channels including a substantially circular primary channel for conveying a first of the medicinal fluids, the primary channel having a primary channel outer circumference defined by the wall inner circumference, a proximal opening fluidically connected to a first of the supplies to supply the first medicinal fluid to the primary channel, and a distal opening fluidically connected to the mixing chamber, a substantially circular secondary channel for conveying a second of the medicinal fluids, the secondary channel entirely disposed between the wall inner circumference and the wall outer circumference and having a proximal opening fluidically connected to a second of the supplies to supply the second medicinal fluid to the secondary channel and a distal opening fluidically connected to the mixing chamber, and a vascular access device fluidically connected to the mixing chamber for simultaneously supplying the at least two medicinal fluids to a patient, the distal opening of the primary channel and the distal opening of the secondary channel substantially preventing over-pressurization of the vascular access device.
With the objects of the invention in view, in combination with a drug delivery system having a medicinal fluid supply system having a distal connector and at least two supplies independently supplying at least two medicinal fluids at the distal connector, a mixing connector defining a mixing chamber, and a vascular access device fluidically connected to the mixing chamber for simultaneously supplying the at least two medicinal fluids to a patient, there is also provided an extension including an intramural extrusion tube for conveying the at least two medicinal fluids independent from one another, the tube having a proximal end connected to the distal connector, a distal end connected to the mixing connector, a single, substantially ring-shaped tubular wall having a wall inner circumference and a wall outer circumference, the wall defining at least two channels including a substantially circular primary channel for conveying a first of the medicinal fluids, the primary channel having a primary channel outer circumference defined by the wall inner circumference, a proximal opening fluidically connected to a first of the supplies to supply the first medicinal fluid to the primary channel, and a distal opening fluidically connected to the mixing chamber for substantially preventing over-pressurization of the vascular access device, and a substantially circular secondary channel for conveying a second of the medicinal fluids, the secondary channel entirely disposed between the wall inner circumference and the wall outer circumference and having a proximal opening fluidically connected to a second of the supplies to supply the second medicinal fluid to the secondary channel and a distal opening fluidically connected to the mixing chamber for substantially preventing over-pressurization of the vascular access device.
With the objects of the invention in view, there is also provided a drug delivery extension, including a mixing connector defining a mixing chamber to be fluidically connected to a vascular access device for simultaneously supplying at least two medicinal fluids to a patient and an intramural extrusion tube for conveying the at least two fluids independent from one another, the tube having a proximal end, a distal end, a single, substantially ring-shaped tubular wall having a wall inner circumference and a wall outer circumference, the wall defining at least two channels including a substantially circular primary channel for conveying a first fluid, the primary channel having a primary channel outer circumference defined by the wall inner circumference and first and second openings respectively opening at the proximal end and the distal end, and a substantially circular secondary channel for conveying a second fluid, the secondary channel entirely disposed between the wall inner circumference and the wall outer circumference and having first and second openings respectively opening at the proximal end and the distal end, the second opening of the primary channel and the second opening of the secondary channel fluidically connected to the mixing chamber and substantially preventing over-pressurization of the vascular access device.
In accordance with another feature of the invention, the mixing connector is a male Luer lock connector. The mixing connector has a size equal to the medical industry standard for insertion into a vascular access device. The term xe2x80x9cstandard,xe2x80x9d as it is used herein, relates to the industry standard corresponding to ISO 594-1:1986.
In accordance with a further feature of the invention, the vascular access device is a catheter.
In accordance with an added feature of the invention, the intramural extrusion tube conveys at least three medicinal fluids independent from one another, the wall defines at least three channels including a substantially circular second secondary channel for conveying a third of the medicinal fluids, and the second secondary channel is entirely disposed between the wall inner circumference and the wall outer circumference and has a proximal opening capable of being fluidically connected to a third of the supplies to supply the third medicinal fluid to the second secondary channel and a distal opening fluidically connected to the mixing chamber for substantially preventing over-pressurization of the vascular access device.
In accordance with an additional feature of the invention, the secondary channel has an outer circumference, the second secondary channel has an outer circumference, and the primary channel outer circumference is entirely outside the outer circumferences of the first and second secondary channels or each of the primary channel outer circumference, the outer circumference of the secondary channel, and the outer circumferences of second secondary channel are entirely separate from one another.
In accordance with yet another feature of the invention, the first opening at the proximal end of the secondary channel is to be fluidically connected to a first syringe, the first opening at the proximal end of the second secondary channel is to be fluidically connected to a second syringe, and/or the first opening at the proximal end of the primary channel is to be fluidically connected to a bag of saline.
In accordance with yet a further feature of the invention, the primary channel has an internal diameter at least as large as the medical industry standard for infusion tubing. In particular, the primary channel has an internal diameter of approximately 0.122 inches.
In accordance with yet an added feature of the invention, the second channel has no decreasing effect on the internal diameter of the primary channel and/or each of the second channel and the second secondary channel have no decreasing effect on the internal diameter of the primary channel.
In accordance with yet an additional feature of the invention, the tube has a length and the primary channel and each secondary channel extend through an entirety of the length.
In accordance with again another feature of the invention, each of the secondary channel and the second secondary channel has an internal diameter between 0.030 and 0.050 inches.
In accordance with again a further feature of the invention, the wall defines a substantially circular third secondary channel for conveying a fourth fluid and the third secondary channel is entirely disposed between the wall inner circumference and the wall outer circumference and has first and second openings respectively opening at the proximal end and the distal end, the second opening of the third secondary channel is fluidically connected to the mixing chamber and substantially prevents over-pressurization of the vascular access device.
In accordance with again an added feature of the invention, the wall defines a substantially circular fourth secondary channel for conveying a fifth fluid and the fourth secondary channel is entirely disposed between the wall inner circumference and the wall outer circumference and has first and second openings respectively opening at the proximal end and the distal end, the second opening of the fourth secondary channel is fluidically connected to the mixing chamber and substantially prevents over-pressurization of the vascular access device.
In accordance with again an additional feature of the invention, the wall defines a substantially circular fifth secondary channel for conveying a sixth fluid and the fifth secondary channel is entirely disposed between the wall inner circumference and the wall outer circumference and has first and second openings respectively opening at the proximal end and the distal end, the second opening of the fifth secondary channel is fluidically connected to the mixing chamber and substantially prevents over-pressurization of the vascular access device.
With the objects of the invention in view, there is also provided a method for conveying at least two medicinal fluids independent from one another, which includes the steps of providing a mixing connector defining a mixing chamber to be fluidically connected to a vascular access device for simultaneously supplying the at least two medicinal fluids to a patient, co-extruding a single, substantially ring-shaped tubular wall having a wall inner circumference, a wall outer circumference, a proximal end, and a distal end, the wall defining at least two channels including a substantially circular primary channel for conveying a first of the fluids, the primary channel having a primary channel outer circumference defined by the wall inner circumference and first and second openings respectively opening at the proximal end and the distal end, and a substantially circular secondary channel for conveying a second of the fluids, the secondary channel being entirely disposed between the wall inner circumference and the wall outer circumference and having first and second openings respectively opening at the proximal end and the distal end, and fluidically connecting the second opening of the primary channel and the second opening of the secondary channel to the mixing chamber and, thereby, substantially prevent over-pressurization of the vascular access device.
In accordance with still another mode of the invention, there are also provided the steps of co-extruding the wall with a substantially circular second secondary channel for conveying a third of the fluids, the second secondary channel being entirely disposed between the wall inner circumference and the wall outer circumference and having first and second openings respectively opening at the proximal end and the distal end and fluidically connecting the second opening of the second secondary channel to the mixing chamber and, thereby, substantially prevent over-pressurization of the vascular access device.
With the objects of the invention in view, there is also provided a method for delivering at least two medicinal fluids, which includes the steps of providing a medicinal fluid supply system having a distal connector and at least two supplies independently supplying at least two medicinal fluids at the distal connector, providing a mixing connector having an inlet and an outlet and defining a mixing chamber fluidically connected to the inlet and the outlet, co-extruding a single, substantially ring-shaped tubular wall having a wall inner circumference, a wall outer circumference, a proximal end, and a distal end, the wall defining at least two channels including a substantially circular primary channel for conveying a first of the fluids, the primary channel having a primary channel outer circumference defined by the wall inner circumference, a proximal opening, and a distal opening, a substantially circular secondary channel for conveying a second of the fluids, the secondary channel entirely disposed between the wall inner circumference and the wall outer circumference and having a proximal opening and a second opening, and connecting the proximal end of the wall to the distal connector to fluidically connect the proximal opening of the primary channel to a first of the supplies to supply the first fluid to the primary channel and fluidically connect the proximal opening of the secondary channel to a second of the supplies to supply the second fluid to the secondary channel, connecting the distal end of the wall to the inlet of the mixing connector to fluidically connect the distal opening of the primary channel to the input of the mixing chamber, fluidically connect the second opening of the secondary channel to the input of the mixing chamber, and fluidically connecting a vascular access device to the outlet of the mixing chamber for simultaneously supplying the at least two medicinal fluids to a patient, the distal opening of the primary channel and the second opening of the secondary channel substantially preventing over-pressurization of the vascular access device.
With the objects of the invention in view, there is also provided a method for delivering at least three medicinal fluids, which includes the steps of providing a medicinal fluid supply system having a distal connector and at least three supplies independently supplying at least three medicinal fluids at the distal connector, providing a mixing connector having an inlet and an outlet and defining a mixing chamber fluidically connected to the inlet and the outlet, co-extruding a single, substantially ring-shaped tubular wall having a wall inner circumference, a wall outer circumference, a proximal end, and a distal end, the wall defining at least three channels including a substantially circular primary channel for conveying a first of the fluids, the primary channel having a primary channel outer circumference defined by the wall inner circumference, a proximal opening, and a distal opening, a substantially circular first secondary channel for conveying a second of the fluids, the first secondary channel entirely disposed between the wall inner circumference and the wall outer circumference and having a proximal opening and a second opening, a substantially circular second secondary channel for conveying a third of the fluids, the second secondary channel entirely disposed between the wall inner circumference and the wall outer circumference and having a proximal opening and a second opening, and connecting the proximal end of the wall to the distal connector to fluidically connect the proximal opening of the primary channel to a first of the supplies to supply the first fluid to the primary channel, fluidically connect the proximal opening of the first secondary channel to a second of the supplies to supply the second fluid to the first secondary channel, and fluidically connect the proximal opening of the second secondary channel to a third of the supplies to supply the third fluid to the second secondary channel, connecting the distal end of the wall to the inlet of the mixing connector to fluidically connect the distal opening of the primary channel to the input of the mixing chamber, fluidically connect the second opening of the first secondary channel to the input of the mixing chamber and fluidically connect the second opening of the second secondary channel to the input of the mixing chamber, and fluidically connecting a vascular access device to the outlet of the mixing chamber for simultaneously supplying the at least three medicinal fluids to a patient, the distal opening of the primary channel, the second opening of the secondary channel, and the second opening of the second secondary channel substantially preventing over-pressurization of the vascular access device.
Other features that are considered as characteristic for the invention are set forth in the appended claims.
Although the invention is illustrated and described herein as embodied in a multi-lumen intravenous extension and method for conveying medicinal fluids, it is, nevertheless, not intended to be limited to the details shown because various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.
The construction and method of operation of the invention, however, together with additional objects and advantages thereof, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings.